COMPUTER SYSTEM VALIDATION ENGINEER

Responsibilities

Lead the design, development, implementation, and execution of test scripts / test plans to identify software problems and their causes.

Coordinate and execute performance and functional testing associated with multiple concurrent development and / or infrastructure projects.

Perform testing of the entire SDLC, including version / change control and new software rollouts.

Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.

Author and execute Installation and Operational Qualification (IQ / OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.

Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.

Author IQ / OQ protocols for new or used equipment purchased.

Review IQ / OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.

Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.

Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).

Requirements

BS in Engineering, Science, or equivalent technical degree.

7+ years experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.

Excellent written and verbal communication skills; excellent technical writing skills.

Strong interpersonal skills and the ability to work in a team environment.

Ability to work effectively in a fast-paced multitasking environment.

Strong working knowledge of FDA and cGMP regulations and documentation practices.

Proficient in Microsoft Word, Excel, PowerPoint.

J-18808-Ljbffr